MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CERCLAGE SUTURE; CERCLAGE, FIXATION

Model Number	FIBERTAPE CERCLAGE SUTURE
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
An arthrex employee has reported that a patient underwent a early-onset scoliosis correction.It was further reported that a arthrex fiber tape was used and broke after the initial surgery and therefore a revision was performed.No further information received.

• Brand Name: FIBERTAPE CERCLAGE SUTURE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10567086
• Report Number: 1220246-2020-02199
• Device Sequence Number: 2671208
• Product Code: JDQ
• UDI-Device Identifier: 00888867274129
• UDI-Public: 00888867274129
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K170206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FIBERTAPE CERCLAGE SUTURE
• Device Catalogue Number: AR-7267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other